Quality assessment of different brands of diclofenac tablets marketed in Ilorin metropolis: a pharmaceutical and public health perspective
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Date
2020-04
Journal Title
Journal ISSN
Volume Title
Publisher
Nigerian Journal of Pharmacy. Published by the Pharmaceutical Society of Nigeria.
Abstract
Background: The quality of a medicinal product is an important factor for its safety and efficacy. Poor-quality
medicines are a major impediment to improvements in public health. This study assessed the pharmaceutical
quality of different brands of diclofenac (DCF) tablets in Ilorin metropolis.
Methods: Four randomly selected brands of diclofenac potassium tablets (coded: DCF-A, DCF-B, DCF-C and DCF-D)
were obtained from pharmaceutical outlets, and quality parameters were evaluated according to Pharmacopeial
methods. The potency of tablets was determined spectrophotometrically based on the measurement of maximum
absorbance at a wavelength of 276 nm in doubly distilled water.
Results: Method validation according to the International Council for Harmonization guidelines showed acceptable
sensitivity (limit of detection of 0.3886 μg/mL and limit of quantication of 1.1775 μg/mL), precision (% relative
standard deviation range of 0.72 – 1.54), accuracy (% recovery range of 98.9 – 101.3). Average contents of active
diclofenac were 45, 98, 103 and 105% for DCF-A, DCF-B, DCF-C and DCF-D respectively. DCF-A brand was not only
substandard but falsied based on British Pharmacopoeia potency specication range of 95 – 105%.
Conclusion: A substandard and falsied brand of diclofenac tablets was detected. Drug regulatory authority must
ensure periodic post-registration surveillance of licensed pharmaceutical products marketed in the country to
secure the health and safety of the populace.
Description
Keywords
diclofenac tablets, spectrophotometric analysis, quality, substandard, falsied medicines